AvenovaTM as a Sterile Skin Preparation Agent

NCT02990013 | Completed Early Phase 1 DMC FDA Device

• 1 other identifier: 20160881
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Aim 1: To determine in vivo capability of AvenovaTM against common cutaneous microbial biome on human skin Aim 2: To compare to povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol against AvenovaTM as a sterile skin agent

Conditions

Cleaning Product Causing Toxic Effect

Outcome Measures

Primary Outcomes (1)

• Compare the efficacy of Avenova to other standard of care cleansing agents: growth vs. no growth

  Growth or no growth of bacteria in the thioglycollate broth will be noted for the control and each quadrant after cleansing with the 4 agents listed above.

  12 months

Secondary Outcomes (1)

• Bacterial Identification

  12 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

All patients will be in the treatment arm where they will be subject to skin testing with various cleansing agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol

Device: Avenova; Drug: Povidone-iodine 5% solution; Drug: 4% chlorhexidine; Drug: Isopropyl alcohol

Interventions

Avenova DEVICE

Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol

Also known as: hypochlorous acid

Treatment arm

Povidone-iodine 5% solution DRUG

Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol

Also known as: Betadine

Treatment arm

4% chlorhexidine DRUG

Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol

Also known as: No other names

Treatment arm

Isopropyl alcohol DRUG

Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol

Also known as: No other names

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 and above able to provide informed consent to participate Adults attending Dr. Wendy Lee Oculoplastics Clinic

You may not qualify if:

• Adults unable to consent
• Individuals who less than 18 years of age
• Prisoners
• Pregnant women - while these cleansing agents are used on pregnant women as standard cleansing agents, effects to fetus unknown
• Patients currently using oral or topical antimicrobial agents
• History of skin infection to facial injectable of surgery
• Inability to tolerate cleansing procedure
• Inability to sit comfortably for 15 - 30 minutes

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Related Publications (5)

• Collins LK, Knackstedt TJ, Samie FH. Antiseptic use in Mohs and reconstructive surgery: an American College of Mohs Surgery member survey. Dermatol Surg. 2015 Jan;41(1):164-6. doi: 10.1097/DSS.0000000000000202. No abstract available.

  PMID: 25521104 BACKGROUND

• Steinsapir KD, Woodward JA. Chlorhexidine Keratitis: Safety of Chlorhexidine as a Facial Antiseptic. Dermatol Surg. 2017 Jan;43(1):1-6. doi: 10.1097/DSS.0000000000000822.

  PMID: 27399954 BACKGROUND

• Kim HJ, Lee JG, Kang JW, Cho HJ, Kim HS, Byeon HK, Yoon JH. Effects of a low concentration hypochlorous Acid nasal irrigation solution on bacteria, fungi, and virus. Laryngoscope. 2008 Oct;118(10):1862-7. doi: 10.1097/MLG.0b013e31817f4d34.

  PMID: 18677274 BACKGROUND

• Robson MC, Payne WG, Ko F, Mentis M, Donati G, Shafii SM, Culverhouse S, Wang L, Khosrovi B, Najafi R, Cooper DM, Bassiri M. Hypochlorous Acid as a Potential Wound Care Agent: Part II. Stabilized Hypochlorous Acid: Its Role in Decreasing Tissue Bacterial Bioburden and Overcoming the Inhibition of Infection on Wound Healing. J Burns Wounds. 2007 Apr 11;6:e6.

  PMID: 17492051 BACKGROUND

• Debabov D, Noorbakhsh C, Wang L, et al. Avenova™ with Neutrox™ (pure 0.01% HOCl) compared with OTC product (0.02% HOCl). NovaBay Pharmaceuticals, Inc., Emeryville, California, USA.

  BACKGROUND

MeSH Terms

Interventions

Povidone-Iodine; Solutions; Chlorhexidine; 2-Propanol

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines; Propanols; Alcohols

Study Officials

• Wendy Lee

  Bascom Palmer Eye Institute University of Miami, Miller School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Ophthalmology & Dermatology

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 12, 2016
• Study Start: December 1, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)